HALOPERIDOL DECANOATE Drug Patent Profile
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Which patents cover Haloperidol Decanoate, and when can generic versions of Haloperidol Decanoate launch?
Haloperidol Decanoate is a drug marketed by Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Mankind Pharma, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms. and is included in twelve NDAs.
The generic ingredient in HALOPERIDOL DECANOATE is haloperidol decanoate. There are twenty drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the haloperidol decanoate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Haloperidol Decanoate
A generic version of HALOPERIDOL DECANOATE was approved as haloperidol decanoate by FRESENIUS KABI USA on December 19th, 1997.
Summary for HALOPERIDOL DECANOATE
US Patents: | 0 |
Applicants: | 11 |
NDAs: | 12 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 49 |
Clinical Trials: | 8 |
Patent Applications: | 228 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for HALOPERIDOL DECANOATE |
What excipients (inactive ingredients) are in HALOPERIDOL DECANOATE? | HALOPERIDOL DECANOATE excipients list |
DailyMed Link: | HALOPERIDOL DECANOATE at DailyMed |
Recent Clinical Trials for HALOPERIDOL DECANOATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Case Western Reserve University | Phase 3 |
National Institutes of Health (NIH) | Phase 3 |
National Institute of Mental Health (NIMH) | Phase 3 |
Pharmacology for HALOPERIDOL DECANOATE
Drug Class | Typical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for HALOPERIDOL DECANOATE
US Patents and Regulatory Information for HALOPERIDOL DECANOATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 074893-001 | Dec 19, 1997 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Somerset Theraps Llc | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 209101-002 | Jul 3, 2018 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hospira | HALOPERIDOL DECANOATE | haloperidol decanoate | INJECTABLE;INJECTION | 075176-001 | Feb 9, 2000 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |